UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034347 |
|---|---|
| Receipt number | R000039153 |
| Scientific Title | Effect and its underlying mechanism of a test food on cognitive functions |
| Date of disclosure of the study information | 2020/05/31 |
| Last modified on | 2020/10/23 13:16:25 |
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Basic information
Public title
Effect and its underlying mechanism of a test food on cognitive functions
Acronym
Effect and its underlying mechanism of a test food on cognitive functions
Scientific Title
Effect and its underlying mechanism of a test food on cognitive functions
Scientific Title:Acronym
Effect and its underlying mechanism of a test food on cognitive functions
Region
| Japan |
Condition
Condition
None (Healthy adults)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the effect and its underlying mechanism of a test food on cognitive functions
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
EEG measurement
Key secondary outcomes
Tests for cognitive functions Questionnaires
Biochemical examination in blood
Saliva Test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Six tablets containing test food per day for 6 weeks
Interventions/Control_2
Six tablets containing placebo per day for 6 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 45 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Men and women who aware of the forgetfulness between the ages of 45 and 64, when giving the informed consent.
2) Subjects whose primary language is Japanese
3) Subjects who are diagnosed as health at pre-inspection
4) Individuals giving the written informed consen
Key exclusion criteria
1.Subjects or their family having anamnesis of epilepsy
2.Subjects who have anamnesis of cranial nerve disease
3.Subjects who have depressive symptoms or who have been to diagnosed as depressive disorders
4.Subjects who have the history of head surgery or foreign metal in their head
5.Subjects who are being treated with hormone or who have been diagnosed as climacterium
6.Subjects who have anamnesis of heart disease or have heart pacemakers
7.Subjects who have anamnesis of febrile seizures
8.Subjects who have claustrophobia, tinnitus, asthma, or hay fever
9.Subjects who have difficulties in recognition of colors
10.Subjects whose visual or hearing acuity is too low to perform tests, or who have been diagnosed as amblyopia, blindness, or deafness
11.Subjects who may have physical deconditioning due to test foods
12.Subjects who have diseases requiring regular administration, or who have anamnesis of severe diseases
13.Subjects who are being treated for cognitive functions, or who regularly take drugs or health foods which may affect cognitive functions more than once a week
14.Subjects who regularly take foods similar to test foods or energy drinks more than once a week
15.Subjects who are, or are planning to be pregnant or nursing during study
16.Subjects who sometimes have irregular lifestyles during study
17.Heavy drinkers
18.Smokers or subjects who started smoking cessation within 12 months
19.Subjects who have taken the similar cognitive function tests within 12 months
20.Subjects who have done blood transfusion or blood donation within 3 months
21.Subjects who have participated in other clinical studies within 1 month, or who are planning to participate in other clinical studies during this study
22.Subjects who are suspected of dementia.
23.Subjects who are judged as unsuitable due to lifestyle questionnaire
24.Subjects who and whose family work in a company developing functional foods
25Subjects who are judged as unsuitable by doctor for other reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kuniaki Obara |
Organization
Kirin Company, Limited
Division name
Research and Development Division, Research Laboratories for Health Science and Food Technologies
Zip code
Address
1-13-5, Fukuura Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
080-1930-9932
k-obara@kirin.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeru Imai |
Organization
CROee.INC
Division name
Evidence Division
Zip code
Address
2F YS Build. 1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan
TEL
03-5953-2108
Homepage URL
imai@croee.com
Sponsor or person
Institute
CROee.INC
Institute
Department
Personal name
Funding Source
Organization
Kirin Company, Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Keio University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京センタークリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 01 | Day |
Last modified on
| 2020 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039153
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